Evaluating the Utility of Bone Grafts in Open Wedge Corrective Osteotomy and Plate Fixation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2025-12-31

Brief Summary

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INTRODUCTION A variety of bone grafts and substitutes are available for filling bone defects in the distal radius after corrective osteotomy, but the harvesting of bone from the iliac crest is the gold standard as it allows easy access to corticocancellous bone of a desirable quality and quantity. The idea behind bone grafting is to provide optimal bone formation and structural stability, which is crucial for bone healing. However, the harvesting and use of bone from the iliac crest potentially comes with the risk of complications such as delayed union of the osteotomy defect; size mismatch between the graft and the osteotomy defect; longer operation time; donor site morbidity including nerve, arterial, and ureteral injury; herniation of abdominal contents; sacroiliac joint instability; pelvic fractures; hematoma and infection. As these disadvantages of bone grafting can have a major impact on patients' everyday lives, research is needed on whether bone grafting is genuinely necessary during corrective osteotomy and plate fixation of the distal radius

OBJECTIVE The objective of this study is to investigate whether harvested bone graft from the iliac crest necessary is during corrective osteotomy and plate fixation in patients with malunited distal radius fractures.

STUDY DESIGN This is a prospective, randomized, controlled multicenter study. Patients will undergo the following examinations once before the operation and five times afterwards: 1) the patients will fill out three questionnaires, 2) complications will be noted, 3) the wrist function will be measured, and 4) radiographs/CT scans will be made.

STUDY POPULATION All patients over the age of 18 years who have a symptomatic malunion after distal radius fracture and are eligible for surgical correction.

INTERVENTION Surgical correction in the form of open wedge corrective osteotomy and plate fixation without bone grafting.

USUAL CARE Open wedge corrective osteotomy and plate fixation with harvesting bone from the iliac crest.

OUTCOME MEASURES Primary outcomes: complications and quality of life. Secondary outcomes: time to complete bone healing, functional outcomes, and cost effectiveness.

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Detailed Description

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Conditions

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Malunion of Fracture of Radius

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

All included patients will undergo an open wedge osteotomy and plate fixation according to the standard surgical techniques. In one group, the bone defect will be filled with bone graft of the iliac crest after open wedge osteotomy according the standard procedure. The other group includes patients who will not receive any bone grafts. The participating hospitals have extensive experience with both treatments.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

A web based randomisation tool will used for randomization according to the GCP-guidelines. Prestratification per hospital will be performed. Patients and the treating surgeon cannot be blinded for the treatment because a part of these patients will undergo bone grafting derived from the iliac crest. The statistician will be blinded for the treatment.

6.3 Study

Study Groups

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Patients with symptomatic malunion of distal radius receiving bone grafting

Open wedge corrective osteotomy and plate fixation with harvesting and using bone from the iliac crest.

Group Type ACTIVE_COMPARATOR

Group with bone grafting

Intervention Type PROCEDURE

Open wedge corrective osteotomy and plate fixation with harvesting and using bone from the iliac crest.

Patients with symptomatic malunion of distal radius receiving none bone grafts

Open wedge corrective osteotomy and plate fixation without harvesting and using bone from the iliac crest.

Group Type ACTIVE_COMPARATOR

Group without bone grafting

Intervention Type PROCEDURE

Open wedge corrective osteotomy and plate fixation without bone grafting.

Interventions

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Group without bone grafting

Open wedge corrective osteotomy and plate fixation without bone grafting.

Intervention Type PROCEDURE

Group with bone grafting

Open wedge corrective osteotomy and plate fixation with harvesting and using bone from the iliac crest.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients of either sex over the age of 18 years
* Symptomatic malunion of the distal radius
* Eligible for open wedge osteotomy and plate fixation with or without bone grafting from iliac crest.
* Patients are able to undergo postoperative follow-up of at least 12 months.

Exclusion Criteria

* Patients who are pregnant
* Patients who have known systemic or metabolic disorders leading to progressive bone deterioration
* Patients who take chronic use of glucocorticoids.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No